HMG CoA Reductase Market: Competitive Landscape, Pipeline, and Market Analysis 2023

HMG CoA Reductase is an enzyme that plays a crucial role in the synthesis of cholesterol in the body. It is the target of statin medications, which inhibit its activity and reduce cholesterol production. By blocking HMG CoA reductase, statins help lower LDL cholesterol levels and decrease the risk of cardiovascular diseases. HMG CoA reductase inhibitors are primarily used in the treatment of hypercholesterolemia, a condition characterized by high levels of cholesterol in the blood, and prevention of atherosclerosis. These drugs are widely prescribed for various disease indications such as coronary artery disease, stroke, and peripheral arterial disease According to the World Health Organization (WHO), cardiovascular diseases account for the majority of deaths worldwide, with an estimated 17.9 million deaths each year. In Europe, cardiovascular diseases are responsible for over 4 million deaths annually, making it the leading cause of mortality. In the United States, heart disease is the leading cause of death, accounting for more than 650,000 deaths each year. According to the Centers for Disease Control and Prevention (CDC), around 30 million adults in the United States have high cholesterol levels. Moreover, the American Heart Association reports that about 28.5 million adults in the United States would benefit from statin therapy to lower their cardiovascular risk.

The growth of the HMG CoA Reductase market is primarily driven by the increasing prevalence of cardiovascular diseases, rising awareness about the importance of cholesterol management, and the effectiveness of statin medications in reducing the risk of heart-related complications. Companies such as Eli Lilly, Merck (MSD), Daiichi Sankyo, Sanofi, Yuhan Corp, AbbVie, Hanmi, Daewoong Pharma, Boryung Group, Korea Kolmar, JW Pharma, Chong Kun Dang, LG Chem, Alvogen, Ache Lab cater to this category. Moreover, many companies are coming up with new molecules in this space. For instance, MSD is one such company currently conducting a clinical trial of the drug MK-524B for treating dyslipidemia.

Key Developments

• In Feb 2023, Chong Kun Dang Pharmaceutical initiated enrolment in a phase I trial for dyslipidemia (combination therapy, in volunteers) in South Korea 
• In July 2019, Daewoong Pharmaceutical completed a phase III trial of Olomax in hyperlipidemia and hypertension in South Korea

Approved HMG CoA Reductase molecules

• Atorvastatin
• Simvastatin
• Rosuvastatin
• Pravastatin
• Ezetimibe, simvastatin
• Livalo (pitavastatin)
• Lovastatin
• Fluvastatin
• Amlodipine, atorvastatin
• Atorvastatin, ezetimibe
• Cholib (fenofibrate, simvastatin)
• Rosuzet (rosuvastatin, ezetimibe)
• Amlodipine, ezetimibe, rosuvastatin
• Atorvastatin, fenofibrate
• Rosuvastatin, telmisartan
• Altoprev (lovastatin extended-release formulation)
• Livasartan (pitavastatin, valsartan)
• Olomax (amlodipine, olmesartan,rosuvastatin)
• Tuvero (fimasartan, rosuvastatin)
• Newvast (atorvastatin strontium pentahydrate)
• Olostar (rosuvastatin, olmesartan medoxomil)
• Dukaro (amlodipine, fimasartan,rosuvastatin)
• Exone-R (amlodipine, rosuvastatin,valsartan)
• Juvisync (sitagliptin, simvastatin)
• Telmiduo Plus (amlodipine, rosuvastatin,telmisartan)
• Telotan (rosuvastatin, telmisartan)
• ZemiStatin (gemigliptin, rosuvastatin FDC)
• Fenofibrate, pravastatin
• Fluvastatin XL
• Advicor (lovastatin, niacin ER)
• Atomet SR (atorvastatin, metformin XR)
• Livasupril (micronized fenofibrate, pitavastatin)
• Rocanduo (candesartan cilexetil, rosuvastatin calcium)
• Rovelito (atorvastatin, irbesartan)
• Simcor (simvastatin, niacin extended-release formulation)
• Rosumet (metformin, rosuvastatin)
• Rovatitan (rosuvastatin, valsartan)
• Simvast CR (simvastatin controlled-release)
• Trezete (ezetimibe, rosuvastatin)
• Amosartan Q (amlodipine, losartan,rosuvastatin)
• ClowZ Tab (ezetimibe, rosuvastatin)
• Copaxone, Zocor (glatiramer acetate,simvastatin)
• Lipimet SR (atorvastatin, metformin)
• Rosuvastatin, valsartan

HMG CoA Reductase Pipeline Molecules

• Laropiprant, niacin,simvastatin (MK-524B)
• Atorvastatin, fenofibrate (CKD-337)
• Modified-release formulation of lovastatin lactone (SYN-010) , Theriva Bio
• Amlodipine, rosuvastatin,telmisartan (YH22189)
• Metformin, rosuvastatin (HCP1201)
• Amlodipine, rosuvastatin (DP-R212)
• Rosuampin (YHP1701)
• Amlodipine, atorvastatin,valsartan (IN-C008)
• Amlodipine, rosuvastatin,telmisartan (DW-1501)
• Atorvastatin immediate-release, losartan potassium delayed-release (HL 040)
• Ezetimibe, rosuvastatin (DP-R207)
• Ezetimibe, rosuvastatin (NVP-1205)
• Rosuvastatin, omega-3 fatty acid (HCP 1007)
• Rosuvastatin, omega-3-acids ethyl esters (HCP1105)
• Metformin, rosuvastatin (BCWP_C003)
• Olpadronic acid (IG-8801)

Clinical Activity and Development of HMG CoA Reductase

In the HMG CoA Reductase space around 10 companies around the world, are conducting more than 100 clinical trials in this category of drugs.  

• In February 2022, AstraZeneca presented pharmacodynamics data from the phase II trial of Rosuvastatin in cardiovascular disorders presented at the 29th Conference on Retroviruses and Opportunistic Infections (CROI-2022)
• In Feb 2023, Kowa presented pharmacodynamics data from a phase II/III reprieve trial of Pitavastatinin in Cardiovascular disorders presented at the 30th Conference on Retroviruses and Opportunistic Infections (CROI-2023)